Friday, December 31, 2010

FDA Tells Public It Cannot Ensure Safety of Drugs that are Approved; What, Then, Is its Mission?

In a Fair Warningarticle about the dangers of the smoking cessation drug Chantix, the Food and Drug Administration was quoted as stating that it cannot ensure the safety of drugs after they are approved - that once drugs are put into widespread use, there is no telling what harms might occur.

According to the article: "Tragedy has plagued Chantix ever since it was approved in May, 2006, even as the drug has helped some smokers kick the habit. By mid-2009, the U.S. Food and Drug Administration had received reports of nearly 100 suicides, 200 attempted suicides and close to 5,000 serious psychiatric events overall. Hundreds of reports of side effects have continued to stream in this year. A review of the drug’s history shows that Pfizer Inc., the giant pharmaceutical company that makes Chantix, failed in its years of clinical trials to test the product on the mentally ill or those with a recent history of depression — even though millions of smokers suffer from psychiatric problems. Moreover, FDA regulators approved Chantix after a speeded-up “priority review” process, and did not request a follow-up study on mentally ill patients using the medication, even though the agency’s own safety reviewer reported that the exclusion of such smokers may have undermined the clinical trials. It wasn’t until three years later, after thousands of reports of serious side effects, that the FDA told Pfizer to conduct trials including people with a history of mental illness." ...

"Pfizer, for its part, defends Chantix and says it “acted responsibly and appropriately at all times in connection with the development, approval, and marketing” of the drug. The FDA, likewise, says it acted properly in approving the drug, despite the problems that emerged after it went on the market."

"“The agency does not feel any mistakes were made,” said FDA spokeswoman Sandy Walsh. “We can never speculate as to what may happen with a drug once it goes into widespread use after approval.”"

The Rest of the Story

It is quite comforting to know that the FDA can never speculate as to what might happen once a drug goes into widespread use after approval.

If the FDA is so unsure of its review process that it cannot even speculate as to the safety of an approved drug, then it's not clear what the purpose of that review process is.

And if the Agency will not acknowledge that any mistakes were made, even though it approved a drug that has killed many people and caused serious adverse consequences for thousands, then why should we believe that Agency review confers any level of safety assurance?

Obviously mistakes were made in the review of Chantix. A product was allowed onto the market which is clearly not safe. This doesn't mean that the Agency is to blame. It simply means that the Agency made a mistake and that the product turned out not to be safe. Arguing that no mistake was made is tantamount to admitting that the Agency is not set up to be able to ensure the safety of the nation's drug supply.

What is particularly troubling to me about the Chantix story is that the very same Agency which allowed this smoking cessation drug - which has killed many users and caused severe health consequences for thousands - to be marketed is now threatening to take electronic cigarettes - which have not been reported to kill or cause severe adverse consequences for a single user - off the market.

Since we know that Chantix is unsafe and can result in suicidal ideation or completed suicide, yet we insist on keeping Chantix on the market, then what justification is there for removing electronic cigarettes from the market even though there are no serious adverse effects yet reported? It just doesn't make any sense.

Speaking of not making any sense, it is even more ridiculous that the FDA now approves the sale and marketing of cigarettes - which kill hundreds of thousands of Americans each year - but has moved to ban electronic cigarettes, a product designed to save the lives of those Americans by giving them an effective alternative to nicotine replacement products for smoking cessation. The FDA would rather people use tobacco cigarettes than electronic ones. By what logic does it make sense to ban the safer cigarettes and approve the real ones?

The rest of the story is that we can all sleep better at night knowing that the Food and Drug Administration acknowledges that it has no idea - it cannot even speculate - as to the safety of drugs once they are approved and put into widespread use by consumers.

This story exposes the absolute folly of putting the regulation of cigarettes into the hands of the FDA. It completely undermines the mission of the Agency, a mission which it is already having a difficult enough time carrying out.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.